Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Uteroplacental Perfusion
研究概览
简要总结
The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.
详细描述
Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications.
Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion.
Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies.
Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR.
Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •FGR pregnancies in 24-37 weeks of GA
排除标准
- •vasodilator agents usage
- •history of cardiovascular morbidity specially of right heart side
- •drug or alcohol abusers
- •systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg
研究组 & 干预措施
sildenafil
干预措施: sildenafil (Drug)
Placebo control
干预措施: placebo (Drug)
结局指标
主要结局
Uteroplacental Perfusion
时间窗: 2 hours after sildenafil ingestion
次要结局
- fetal growth(after 6 months)
- umbilical artery blood gass assessment(immediately after birth)
- effect on fetal well being(2 hours after sildenafil)